Gadoterate (Intravenous route)
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73m(2)), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, older than 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing .
Uses of This Medicine:
Gadoterate is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of diagnostic procedure. They use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation. Gadoterate is a gadolinium-based contrast agent (GBCA).
Gadoterate is given by injection before MRI to help diagnose problems in the brain, spine, head, neck, and other parts of your body.
This medicine is to be used only by or under the direct supervision of a doctor.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadoterate in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadoterate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving gadoterate.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Asthma or allergies, history of or
- Patients who have had prior reactions to contrast media—Use with caution. May increase the likelihood of an allergic reaction.
- Diabetes or
- Hypertension (high blood pressure)—Use with caution. May increase your likelihood of having reduced kidney function.
- Kidney disease, mild or moderate—Use with caution. May increase the likelihood of serious side effects.
- Kidney problems, severe (acute or long-term)—Should not be used in patients with this condition.
Proper Use of This Medicine:
A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins just before you have an MRI scan.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child while you are receiving this medicine and during the MRI scan. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.
The risk of having a very serious disease called nephrogenic systemic fibrosis (NSF) is increased in patients with severe kidney disease. Even if you have severe kidney problems, your doctor may decide that it is still important to use this medicine. Check with your doctor right away if you or your child have burning or itching of the skin, red or dark patches on the skin, swelling, hardening, or tightening of the skin, joint stiffness, limited range of motion in the arms and legs, pain that is deep in the hip bone or ribs, or muscle weakness. These may be symptoms of NSF.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, trouble with breathing, or chest pain after you receive the medicine.
Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.
Side Effects of This Medicine:
- Blurred vision
- fast, irregular, pounding, or racing heartbeat or pulse
- pounding in the ears
- slow or fast heartbeat
- Incidence not known
- Areas of the skin that turn red or dark or feel tight
- bluish color of the fingernails, lips, skin, palms, or nail beds
- bone pain in the hips or ribs
- burning, dry, or itching eyes
- change in consciousness
- chest pain or discomfort
- difficulty with swallowing
- discharge or excessive tearing
- hives or welts
- increased sweating
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- loss of consciousness
- muscle weakness
- no blood pressure or pulse
- no breathing
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- shakiness in the legs, arms, hands, or feet
- skin rash
- skin that burns or itches, swells, scales, or hardens
- stiff joints or muscles
- stopping of the heart
- trembling or shaking of the hands or feet
- trouble moving your arms or legs
- unusual tiredness or weakness
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- discomfort in the throat
- loss of taste
- pain in the arms or legs
- pain, burning, or cold sensation at the injection site
- sleepiness or unusual drowsiness
- Incidence not known
- Transient, mild, pleasant aromatic odor
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014